Blood sample management using open cell foam

ABSTRACT

A specimen transfer device adapted to receive a blood sample is disclosed. The specimen transfer device includes a housing and an actuation member. A deformable material is disposed within the housing and is deformable from an initial position in which the material is adapted to hold the sample to a deformed position in which at least a portion of the sample is released from the material. A viscoelastic member is disposed within the housing between the material and the housing and between the material and the actuation member. The viscoelastic member is engaged with the actuation member and the material such that movement of the actuation member from a first position to a second position deforms the material from the initial position to the deformed position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 62/063,536, entitled “Blood Sample Management Using Open Cell Foam”filed Oct. 14, 2014, and U.S. Provisional Application Ser. No.62/207,618, entitled “Blood Sample Management Using Open Cell Foam”filed Aug. 20, 2015, the entire disclosures of each of which are hereinincorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Disclosure

The present disclosure relates generally to a blood transfer device.More particularly, the present disclosure relates to a blood transferdevice, a blood transfer and testing system, a lancet and blood transferdevice, and a method of loading an anticoagulant.

2. Description of the Related Art

Blood sampling is a common health care procedure involving thewithdrawal of at least a drop of blood from a patient. Blood samples arecommonly taken from hospitalized, homecare, and emergency room patientseither by finger stick, heel stick, or venipuncture. Once collected,blood samples may be analyzed to obtain medically useful informationincluding, for example, chemical composition, hematology, andcoagulation.

Blood tests determine the physiological and biochemical states of thepatient, such as disease, mineral content, drug effectiveness, and organfunction. Blood tests may be performed in a clinical laboratory or atthe point-of-care near the patient.

SUMMARY OF THE INVENTION

The present disclosure provides a blood transfer device adapted toreceive a blood sample. The blood transfer device includes a housinghaving a first end, a second end, a sidewall extending therebetween, andan actuation member movable between a first position and a secondposition. A deformable material is disposed within the housing and isdeformable from an initial position in which the material is adapted tohold the blood sample to a deformed position in which a portion of theblood sample is released from the material. A viscoelastic member isdisposed within the housing between the material and the sidewall of thehousing and between the material and the actuation member. Theviscoelastic member is engaged with the actuation member and thematerial such that movement of the actuation member from the firstposition to the second position exerts a force on the viscoelasticmember which redistributes the force evenly over the material anddeforms the material from the initial position to the deformed position.

In accordance with an embodiment of the present invention, a specimentransfer device adapted to receive a sample includes a housing having afirst end, a second end, a sidewall extending therebetween, and anactuation member movable between a first position and a second position.The device further includes a deformable material disposed within thehousing, in which the material is deformable from an initial position inwhich the material is adapted to contain the sample, to a deformedposition in which at least a portion of the sample is released from thematerial. The device also includes a viscoelastic member disposed withinthe housing between the material and the sidewall of the housing andbetween the material and the actuation member. The viscoelastic memberis engaged with the actuation member and the material such that movementof the actuation member from the first position to the second positionexerts a force on the viscoelastic member which deforms the materialfrom the initial position to the deformed position.

In certain configurations, the deformable material includes pores. Thedevice may also include a dry anticoagulant powder disposed within thepores of the material. The housing may also include a dispensing tip atthe first end. Optimally, the housing includes a valve disposed withinthe dispensing tip, with the valve being transitionable between a closedposition and an open position. With the material in the deformedposition and the valve in the open position, the at least a portion ofthe sample may be released from the material and may flow through thedispensing tip.

In certain configurations, the viscoelastic member has a viscoelasticmember hardness. The actuation member may also have an actuation memberhardness. In certain configurations, the viscoelastic member hardness isless than the actuation member hardness. The actuation member may belocated at the second end of the housing. Optionally, the actuationmember may be a push button, and the sample may be blood.

In accordance with another embodiment of the present invention, aspecimen transfer and testing system may include a specimen transferdevice adapted to receive a sample. The specimen transfer device mayinclude a housing having a first end, a second end, a sidewall extendingtherebetween, a dispensing tip at the first end, an actuation member atthe second end, and a valve disposed within the dispensing tip. Theactuation member may be movable between a first position and a secondposition, and the valve may be transitionable between a closed positionand an open position. The specimen transfer device may also include adeformable material having pores and disposed within the housing, withthe material deformable from an initial position in which the materialis adapted to contain the sample to a deformed position in which atleast a portion of the sample is released from the material. Thespecimen transfer device may also include a viscoelastic member disposedwithin the housing between the material and the sidewall of the housingand between the material and the actuation member. The viscoelasticmember may be engaged with the actuation member and the material suchthat movement of the actuation member from the first position to thesecond position exerts a force on the viscoelastic member which deformsthe material from the initial position to the deformed position. Withthe material in the deformed position and the valve in the openposition, the portion of the sample released from the material may flowthrough the dispensing tip. The specimen transfer and testing system mayalso include a sample testing device having a receiving port adapted toreceive the dispensing tip of the specimen transfer device for closedtransfer of at least a portion of the sample from the specimen transferdevice to the sample testing device.

In certain configurations, the specimen transfer device further includesa dry anticoagulant powder within the pores of the material. Theviscoelastic member may have a viscoelastic member hardness, theactuation member may have an actuation member hardness, and theviscoelastic member hardness may be less than the actuation memberhardness. In certain configurations, the actuation member is a pushbutton. In other configurations, the specimen is blood.

In accordance with yet another embodiment of the present invention, alancet and specimen transfer device includes a lancet housing having aforward end, a rearward end, and a puncturing element, the puncturingelement at least partially disposed within the lancet housing andadapted for movement between a pre-actuated position wherein thepuncturing element is retained within the lancet housing and apuncturing position wherein at least a portion of the puncturing elementextends through the forward end of the lancet housing. The lancet andspecimen transfer device further includes a specimen transfer deviceengageable with the rearward end of the lancet housing.

In accordance with another embodiment of the present invention, a bloodtransfer device adapted to receive a blood sample includes a housinghaving a first end, a second end, and an actuation member transitionablebetween a first position and a second position. The blood transferdevice further includes an open cell foam material disposed within thehousing and having a dry anticoagulant powder therein.

In certain configurations, the blood transfer device also includes acapillary tube in fluid communication with the open cell foam material.The housing may also include a lid movable between a closed position inwhich the open cell foam material is sealed within the housing and anopen position in which a portion of the open cell foam material isexposed. The capillary tube may be adapted to receive the blood sampleafter the blood sample is mixed with the dry anticoagulant powder withinthe open cell foam material. The capillary tube may include a dispensingtip.

Movement of the actuation member from the first position to the secondposition may dispense the blood sample through the dispensing tip of thecapillary tube. The first capillary tube may be disposed between thefirst end of the housing and the open cell foam material. The device mayalso include a second capillary tube in fluid communication with theopen cell foam material, with the second capillary tube disposed betweenthe second end of the housing and the open cell foam material. Thesecond capillary tube may be adapted to receive the blood sample afterthe blood sample is mixed with the dry anticoagulant powder within theopen cell foam material. Movement of the actuation member from the firstposition to the second position may dispense the blood sample through adispensing tip of the second capillary tube. At least one of an internalsurface of the first capillary tube and an internal surface of thesecond capillary tube may include an anticoagulant coating. The firstcapillary tube and the second capillary tube may have different lengths.Optionally, the first capillary tube and the second capillary tube mayhave different internal diameters.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1A is a schematic representation of a deformable material of ablood transfer device in accordance with an embodiment of the presentinvention.

FIG. 1B is a schematic representation of a deformable material of ablood transfer device in accordance with an embodiment of the presentinvention.

FIG. 1C is a schematic representation of a deformable material of ablood transfer device in accordance with an embodiment of the presentinvention.

FIG. 1D is a schematic representation of a deformable material and aviscoelastic member of a blood transfer device in accordance with anembodiment of the present invention.

FIG. 1E is a schematic representation of a deformable material and aviscoelastic member of a blood transfer device in accordance with anembodiment of the present invention.

FIG. 2 is a cross-sectional front view of a blood transfer device inaccordance with an embodiment of the present invention.

FIG. 3A is a front view of a blood transfer device in accordance with anembodiment of the present invention.

FIG. 3B is a perspective front view of the blood transfer device of FIG.3A during a step of use in accordance with an embodiment of the presentinvention.

FIG. 3C is a front view of the blood transfer device of FIG. 3A during astep of use in accordance with an embodiment of the present invention.

FIG. 4A is a front view of a blood transfer device in accordance with anembodiment of the present invention.

FIG. 4B is a perspective view of a step of using the blood transferdevice of FIG. 4A in accordance with an embodiment of the presentinvention.

FIG. 4C is a perspective view of a step of using the blood transferdevice of FIG. 4A in accordance with an embodiment of the presentinvention.

FIG. 4D is a perspective view of a step of using the blood transferdevice of FIG. 4A in accordance with an embodiment of the presentinvention.

FIG. 4E is a perspective view of a step of using the blood transferdevice of FIG. 4A in accordance with an embodiment of the presentinvention.

FIG. 5A is a front view of a blood transfer device in accordance with anembodiment of the present invention.

FIG. 5B is a perspective view of a step of using the blood transferdevice of FIG. 5A in accordance with an embodiment of the presentinvention.

FIG. 5C is a perspective view of a step of using the blood transferdevice of FIG. 5A in accordance with an embodiment of the presentinvention.

FIG. 5D is a perspective view of a step of using the blood transferdevice of FIG. 5A in accordance with an embodiment of the presentinvention.

FIG. 6A is a front view of a lancet and blood transfer device inaccordance with an embodiment of the present invention.

FIG. 6B is a perspective view of a step of using the lancet and bloodtransfer device of FIG. 6A in accordance with an embodiment of thepresent invention.

FIG. 6C is a perspective view of a step of using the lancet and bloodtransfer device of FIG. 6A in accordance with an embodiment of thepresent invention.

FIG. 6D is a perspective view of a step of using the lancet and bloodtransfer device of FIG. 6A in accordance with an embodiment of thepresent invention.

FIG. 7A is a front view of a blood transfer device in accordance with anembodiment of the present invention.

FIG. 7B is a front view of a step of using the blood transfer device ofFIG. 7A in accordance with an embodiment of the present invention.

FIG. 7C is a front view of a step of using the blood transfer device ofFIG. 7A in accordance with an embodiment of the present invention.

FIG. 7D is a front view of a step of using the blood transfer device ofFIG. 7A in accordance with an embodiment of the present invention.

FIG. 8 is a top view of a blood transfer device kit in accordance withan embodiment of the present invention.

FIG. 9 is a cross-sectional front view of a blood transfer device inaccordance with an embodiment of the present invention.

FIG. 10 is a front view of a step of using the blood transfer device ofFIG. 9 in accordance with an embodiment of the present invention.

FIG. 11 is a front view of a step of using the blood transfer device ofFIG. 9 in accordance with an embodiment of the present invention.

FIG. 12 is a front view of a step of using the blood transfer device ofFIG. 9 in accordance with an embodiment of the present invention.

FIG. 13 is a front view of a step of using the blood transfer device ofFIG. 9 in accordance with an embodiment of the present invention.

FIG. 14 is a cross-sectional front view of a blood transfer device inaccordance with an embodiment of the present invention.

FIG. 15 is a front view of a step of using the blood transfer device ofFIG. 14 in accordance with an embodiment of the present invention.

FIG. 16 is a front view of a step of using the blood transfer device ofFIG. 14 in accordance with an embodiment of the present invention.

FIG. 17 is a front view of a step of using the blood transfer device ofFIG. 14 in accordance with an embodiment of the present invention.

FIG. 18 is a front view of a step of using the blood transfer device ofFIG. 14 in accordance with an embodiment of the present invention.

FIG. 19 is a perspective view of a syringe assembly in accordance withan embodiment of the present invention.

FIG. 20 is a close-up partial perspective view of the syringe assemblyof FIG. 19 in accordance with an embodiment of the present invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

FIG. 2 illustrates an exemplary embodiment of a blood transfer device ofthe present disclosure. Referring to FIG. 2, a blood transfer device 10adapted to receive a blood sample 12 (FIG. 3B) includes a housing orbody 14, a deformable material 16, and a viscoelastic member 18.

In one embodiment, housing 14 includes a first end 20, a second end 22,a sidewall 24 extending therebetween, a dispensing tip 26 at the firstend 20, an actuation member 28 at the second end 22, a valve 30, a cap32, and a finger flange 34.

The blood transfer device 10 may include an actuation member 28 that ismovable between a first position and a second position. In oneembodiment, the actuation member 28 is located at the second end 22 ofthe housing 14. In one embodiment, the actuation member 28 is a pushbutton. The actuation member has an actuation member hardness.

The blood transfer device 10 may include a cap 32 for protectivelycovering the blood transfer device 10 prior to use thereof. In oneembodiment, the cap 32 protectively covers the dispensing tip 26 of theblood transfer device 10 prior to use thereof.

The blood transfer device 10 may include a valve 30 that istransitionable between a closed position and an open position. In oneembodiment, the valve 30 is disposed within the dispensing tip 26. Withthe valve 30 in an open position, a portion of the blood sample 12 thatis released from the material 16 is able to flow through the dispensingtip 26. In one embodiment, a portion of the blood sample 12 that isreleased from the material 16 is able to flow through the dispensing tip26 to a blood testing device 60. With the valve 30 in a closed position,no portion of the blood sample 12 is able to flow from the bloodtransfer device 10.

Referring to FIGS. 3A-7D, a blood testing device 60 includes a receivingport 62 adapted to receive the dispensing tip 26 of the blood transferdevice 10. The blood testing device 60 is adapted to receive thedispensing tip 26 of the blood transfer device 10 for closed transfer ofa portion of the blood sample 12 (FIG. 3C) from the material 16 of theblood transfer device 10 to the blood testing device 60. The bloodtesting device 60 is adapted to receive the blood sample 12 to analyzethe blood sample and obtain test results. In one embodiment, the bloodtesting device 60 is a point-of-care testing device.

In one embodiment, material 16 includes pores 40 (FIG. 2) and isdisposed within the housing 14 of the blood transfer device 10. Thematerial 16 is deformable from an initial position in which the material16 is adapted to hold the blood sample 12 to a deformed position inwhich a portion of the blood sample 12 is released from the material 16.In one embodiment, the material 16 includes a dry anticoagulant powder42 within the pores 40 of the material 16. A method of loading ananticoagulant to a material 16 having pores 40 is described in moredetail below.

In one embodiment, the material 16 is a sponge material. In oneembodiment, the material 16 is an open cell foam. In one embodiment, theopen cell foam is treated with an anticoagulant, as described in detailbelow, to form a dry anticoagulant powder finely distributed throughoutthe pores 40 of the material 16. The open cell foam may be loaded with ablood sample. The blood gets soaked into the open cell foam based oncapillary principles. As the blood is loaded into the open cell foam,the blood is exposed to the anticoagulant powder throughout the internalmicro pore structure of the open cell foam. Once the open cell foam isloaded with the blood, the open cell foam may be deformed, e.g.,compressed, to squeeze-out a stabilized blood sample. In one embodiment,the stabilized blood sample may be transferred to a diagnosticinstrument such as a blood testing device, a point-of-care testingdevice, or similar analytical device.

In one embodiment, the material 16 is a soft deformable open cell foamthat is inert to blood. In one embodiment, the open cell foam may be amelamine foam, such as Basotect® foam commercially available from BASF.In another embodiment, the open cell foam may consist of aformaldehyde-melamine-sodium bisulfite copolymer. The open cell foam maybe a flexible, hydrophilic open cell foam that is resistant to heat andmany organic solvents. In one embodiment, the open cell foam may be asponge material.

A method of loading an anticoagulant to a material 16 having pores 40will now be discussed. In one embodiment, the method includes soakingthe material 16 in a liquid solution of the anticoagulant and water;evaporating the water of the liquid solution; and forming a dryanticoagulant powder 42 within the pores 40 of the material 16.

The method of the present disclosure enables precisely controlledloading of an anticoagulant into the material 16 by soaking it with ananticoagulant and water solution and then drying the material 16 to forma finely distributed dry anticoagulant powder 42 throughout the pores 40of the material 16.

Anticoagulants such as Heparin or EDTA (Ethylene Diamine Tetra AceticAcid) as well as other blood stabilization agents could be introducedinto the material 16 as a liquid solution by soaking the material 16 inthe liquid solution of a desired concentration. After evaporating theliquid phase, e.g., evaporating the water from a water and Heparinsolution, a dry anticoagulant powder may be formed and finelydistributed throughout the internal structure of the material 16. Forexample, the dry anticoagulant powder may be finely distributedthroughout the pores 40 of the material 16. In a similar manner, thematerial 16 could be treated to provide a hydrophobic, hydrophilic, orreactive internal pore surface.

In one embodiment, the viscoelastic member 18 is disposed within thehousing 14 of the blood transfer device 10 between the material 16 andthe sidewall 24 of the housing 14 and between the material 16 and theactuation member 28. For example, referring to FIG. 2, the viscoelasticmember 18 includes a first portion 50 that is disposed between thematerial 16 and the sidewall 24 of the housing 14 and a second portion52 that is disposed between the material 16 and the actuation member 28.

Viscoelastic member 18 of an exemplary embodiment is preferably made ofa pliable material, such as a soft elastomer, for example. In oneexemplary embodiment, viscoelastic member 18 is made from a viscoelasticmaterial such as silicone or a thermoplastic elastomer (TPE). Theviscoelastic member 18 serves as an intermediate member between thematerial 16 and the rigid surrounding components, e.g., the sidewall 24of the housing 14 and the actuation member 28. In one embodiment, theviscoelastic member 18 serves as a damper or a soft viscoelastic damper.The viscoelastic member 18 uniformly redistributes the external imposedstrain to the material 16 via the actuation member 28 as describedbelow. In this manner, the viscoelastic member 18 minimizes bloodhemolysis due to localized excessive deformation of the material 16.Additionally, the viscoelastic member 18 controls the speed of thedeformation of the material 16 and mitigates the rate of the forceapplied to deform the material 16 via the actuation member 28.

The viscoelastic member 18 has a viscoelastic member hardness. Theviscoelastic member hardness is less than the actuation member hardness.In one embodiment, the viscoelastic member hardness of the material thatforms viscoelastic member 18 may have a hardness value on the ShoreDurometer scale in the type A range for soft elastomers. In oneexemplary embodiment, viscoelastic member 18 has a hardness ofapproximately Shore A 5.

The blood transfer device 10 may include a finger flange 34. When it isdesired to expel or deliver a portion of the blood sample 12 from thematerial 16, the blood transfer device 10 is grasped with the user'sthumb on the actuation member 28 and with the user's fingers extendingaround the finger flange 34. In this manner, the blood transfer device10 is grasped by a user in a well-known and well recognized mannersimilar to the operation of a conventional hypodermic syringe. Next, theuser effects a squeezing movement between the thumb on the actuationmember 28 and the fingers grasping the finger flange 34, thereby causingthe actuation member 28 to move in a direction generally along arrow A(FIG. 2) from a first position to a second position.

The viscoelastic member 18 is engaged with the actuation member 28 andthe material 16 such that movement of the actuation member 28 from thefirst position to the second position exerts a force on the viscoelasticmember 18 which redistributes the force evenly over the material 16 anddeforms the material 16 from the initial position to the deformedposition. In this manner, the viscoelastic member 18 minimizes bloodhemolysis due to localized excessive deformation of the material 16.Additionally, the viscoelastic member 18 controls the speed of thedeformation of the material 16 and mitigates the rate of the forceapplied to deform the material 16 via the actuation member 28.

With the material 16 in the deformed position and the valve 30 of thehousing 14 in the open position, the portion of the blood sample 12released from the material 16 is able to flow through the dispensing tip26.

FIGS. 3A-7D illustrate other exemplary embodiments. The embodimentillustrated in FIGS. 3A-3C includes similar components to the embodimentillustrated in FIG. 2, and the similar components are denoted by areference number followed by the letter A. The embodiment illustrated inFIGS. 4A-4E also includes similar components to the embodimentillustrated in FIG. 2, and the similar components are denoted by areference number followed by the letter B. The embodiment illustrated inFIGS. 5A-5D also includes similar components to the embodimentillustrated in FIG. 2, and the similar components are denoted by areference number followed by the letter C. The embodiment illustrated inFIGS. 6A-6D also includes similar components to the embodimentillustrated in FIG. 2, and the similar components are denoted by areference number followed by the letter D. The embodiment illustrated inFIGS. 7A-7D also includes similar components to the embodimentillustrated in FIG. 2, and the similar components are denoted by areference number followed by the letter E. For the sake of brevity,these similar components and the similar steps of using blood transferdevices 10A-10E (FIGS. 3A-7D) will not all be discussed in conjunctionwith the embodiments illustrated in FIGS. 3A-7D.

Referring to FIGS. 3A-3C, in one embodiment, blood transfer device 10Aincludes a body or bellows 70 and a cap 72 that is transitionablebetween an open position and a closed position. In one embodiment, thecap 72 is connected to the bellows 70 via a hinged portion 74.

During the use of blood transfer device 10A, a lancet device can be usedto lance a skin surface S of a patient. Next, the cap 72 is moved to theopen position to expose the material 16A. The blood transfer device 10Ais then positioned such that the material 16A is placed adjacent apunctured skin surface S of a patient so that the blood sample 12 can betransferred to the material 16A. For example, the material 16A may touchthe punctured skin surface S to soak up the blood sample 12. As theblood 12 is loaded into the material 16A, the blood 12 is exposed to theanticoagulant powder throughout the internal micro pore structure of thematerial 16A. Once the material 16A is loaded with the blood 12, the cap72 is moved to the closed position and the material 16A is deformed,e.g., compressed, to squeeze out a stabilized blood sample 12. In oneembodiment, the stabilized blood sample 12 may be transferred to adiagnostic instrument such as a blood testing device 60A.

Referring to FIGS. 4A-4E, in one embodiment, blood transfer device 10Bincludes a first body portion 80, a second body portion 82 connected tothe first body portion 80 via a hinged portion 84, a chamber 86 withinthe first body portion 80 for receiving a material 16B, a protrudingelement 88 extending into the second body portion 82 towards the firstbody portion 80, and a sterile cap 89 in fluid communication with thechamber 86. The blood transfer device 10B is transitionable between anopen position and a closed position.

During the use of blood transfer device 10B, a lancet device 100 can beused to lance a skin surface S of a patient. Next, the blood transferdevice 10B is moved to the open position to expose the material 16Bwithin the chamber 86. The blood transfer device 10B is then positionedsuch that the material 16B is placed adjacent a punctured skin surface Sof a patient so that the blood sample 12 can be transferred to thematerial 16B. For example, the material 16B may touch the punctured skinsurface S to soak up the blood sample 12. As the blood 12 is loaded intothe material 16B, the blood 12 is exposed to the anticoagulant powderthroughout the internal micro pore structure of the material 16B. Oncethe material 16B is loaded with the blood 12, the blood transfer device10B is moved to the closed position and the material 16B is deformed,e.g., compressed, to squeeze out a stabilized blood sample 12. Forexample, the blood transfer device 10B can be squeezed so that theprotruding element 88 deforms the material 16B thereby squeezing astabilized blood sample 12 through the sterile cap 89. In oneembodiment, the stabilized blood sample 12 may be transferred to adiagnostic instrument such as a blood testing device 60B.

Referring to FIGS. 5A-5D, in one embodiment, blood transfer device 10Cincludes a first body portion 90, a second body portion 92 removablyconnected to the first body portion 90, a chamber 94 within the firstbody portion 90 for receiving a material 16C, and a slide button 96movably positioned within the second body portion 92. The blood transferdevice 10C is transitionable between an open position and a closedposition. The slide button 96 is transitionable between a first positionand a second position.

During the use of blood transfer device 10C, a lancet device can be usedto lance a skin surface S of a patient. Next, the second body portion 92is removed from the first body portion 90 to open the blood transferdevice 10C and expose the material 16C within the chamber 94. The bloodtransfer device 10C is then positioned such that the material 16C isplaced adjacent a punctured skin surface S of a patient so that theblood sample 12 can be transferred to the material 16C. For example, thematerial 16C may touch the punctured skin surface S to soak up the bloodsample 12. As the blood 12 is loaded into the material 16C, the blood 12is exposed to the anticoagulant powder throughout the internal micropore structure of the material 16C. Once the material 16C is loaded withthe blood 12, the second body portion 92 is connected to the first bodyportion 90 to close the blood transfer device 10C and the material 16Cis deformed, e.g., compressed, to squeeze out a stabilized blood sample12. For example, the slide button 96 can be moved from the firstposition to the second position to compress the material 16C and squeezea stabilized blood sample 12 through the dispensing tip 26C. In oneembodiment, the stabilized blood sample 12 may be transferred to adiagnostic instrument such as a blood testing device 60C, as shown inFIG. 5D.

FIGS. 6A-6D illustrate another exemplary embodiment of the presentdisclosure. Referring to FIGS. 6A-6D, a lancet and blood transfer device110 includes a lancet device 120 and a blood transfer device 10D.

In one embodiment, lancet device 120 includes a lancet housing 122having a forward end 124 and a rearward end 126, a lancet structure 128having a puncturing element 130, a protective cover 132, and a gripportion 134. In one embodiment, the lancet device 120 is a contactactivated lancet device. The lancet device 120 may include theprotective cover 132 for protectively covering the lancet device 120prior to use thereof. The lancet housing 122 may include the gripportion 134 to generally improve the grip between the lancet housing 122and the user's fingertips.

The lancet structure 128 is at least partially disposed within thelancet housing 122 and is adapted for movement between a pre-actuatedposition wherein the puncturing element 130 is retained within thelancet housing 122 and a puncturing position wherein at least a portionof the puncturing element 130 extends through the forward end 124 of thelancet housing 122.

Referring to FIGS. 6A-6D, in one embodiment, blood transfer device 10Dincludes a chamber 140 within the blood transfer device 10D forreceiving a material 16D, a push button 142 transitionable between afirst position and a second position, and a sterile cap 144transitionable between an open position and a closed position. In oneembodiment, the cap 144 is connected to the blood transfer device 10Dvia a hinged portion 146. In one embodiment, the blood transfer device10D is connected to the rearward end 126 of the lancet housing 122 asshown in FIGS. 6A-6D.

During the use of lancet and blood transfer device 110, the lancetdevice 120 can be used to lance a skin surface S of a patient. Next, thecap 144 of the blood transfer device 10D is moved to the open positionto expose the material 16D within the chamber 140.

The lancet and blood transfer device 110 is then positioned such thatthe material 16D is placed adjacent a punctured skin surface S of apatient so that the blood sample 12 can be transferred to the material16D. For example, the material 16D may touch the punctured skin surfaceS to soak up the blood sample 12. As the blood 12 is loaded into thematerial 16D, the blood 12 is exposed to the anticoagulant powderthroughout the internal micro pore structure of the material 16D. Oncethe material 16D is loaded with the blood 12, the cap 144 is moved tothe closed position to close the blood transfer device 10D and thematerial 16D is deformed, e.g., compressed, to squeeze out a stabilizedblood sample 12. For example, the push button 142 can be moved from thefirst position to the second position to compress the material 16D andsqueeze a stabilized blood sample 12 through the dispensing tip 26D. Inone embodiment, the stabilized blood sample 12 may be transferred to adiagnostic instrument such as a blood testing device 60D.

Referring to FIGS. 7A-7D, in one embodiment, blood transfer device 10Eincludes a first end 150, a second end 152, an internal mechanism withinthe housing 14E of the blood transfer device 10E, and a cap 154 that istransitionable between an open position and a closed position.

During the use of blood transfer device 10E, a lancet device can be usedto lance a skin surface S of a patient. Next, the cap 154 is removed toopen the blood transfer device 10E and expose the material 16E withinthe blood transfer device 10E. The blood transfer device 10E is thenpositioned such that the material 16E is placed adjacent a puncturedskin surface S of a patient so that the blood sample 12 can betransferred to the material 16E. For example, the material 16E may touchthe punctured skin surface S to soak up the blood sample 12. As theblood 12 is loaded into the material 16E, the blood 12 is exposed to theanticoagulant powder throughout the internal micro pore structure of thematerial 16E. Once the material 16E is loaded with the blood 12, the cap154 is connected to the blood transfer device 10E to close the bloodtransfer device 10E and the material 16E is deformed, e.g., compressed,to squeeze out a stabilized blood sample 12. For example, the bloodtransfer device 10E can be pushed down on a surface to trigger theinternal mechanism within the housing 14E of the blood transfer device10E to automatically compress the material 16E and squeeze a stabilizedblood sample 12 through the dispensing tip 26E. In one embodiment, thestabilized blood sample 12 may be transferred to a diagnostic instrumentsuch as a blood testing device 60E.

FIG. 8 illustrates an exemplary embodiment of the present disclosure.Referring to FIG. 8, a lancet and blood transfer system 200 of thepresent disclosure includes a kit 201 having a blood transfer device202, a contact activated lancet device 204, and alcohol swabs 206. Inone embodiment, the components of the kit 201 are packaged together.

Referring to FIGS. 1A-1E, operating principles of embodiments of thepresent disclosure are illustrated. Referring to FIGS. 1B and 1C, adeformable material 16 receives blood 12 therein. As the blood 12 isloaded into the material 16, the blood 12 is exposed to theanticoagulant powder throughout the internal micro pore structure of thematerial 16. Once the material 16 is loaded with the blood 12, thematerial 16 is directly deformed, e.g., compressed, to squeeze out astabilized blood sample 12.

Referring to FIGS. 1D and 1E, a deformable material 16 receives blood 12therein. As the blood 12 is loaded into the material 16, the blood 12 isexposed to the anticoagulant powder throughout the internal micro porestructure of the material 16. Once the material 16 is loaded with theblood 12, the material 16 is indirectly deformed, e.g., compressed, viathe viscoelastic member 18 to squeeze out a stabilized blood sample 12.

A blood transfer device of the present disclosure offers uniform bloodmixing with an anticoagulant throughout micro pores of an open cell foamfor small sample volumes such as capillary blood samples obtained from afinger stick. A blood transfer device of the present disclosure couldcatch blood clots or other contaminants within the pores of the opencell foam and prevent them from being dispensed into a diagnostic sampleport. A blood transfer device of the present disclosure enables asimple, low cost design for receiving and dispensing a blood sample.Blood sample management based on a deformable open cell foam may be usedand adjusted for capillary, venous, and arterial sample management.

FIGS. 9-20 illustrate other exemplary embodiments of the presentdisclosure. The present disclosure also provides a blood transfer devicethat includes an open cell foam material and a capillary tube to collecta blood sample, stabilize the blood sample, e.g., mix the blood samplewith an anticoagulant, meter the blood sample, and dispense thestabilized blood sample to a diagnostic device. The present disclosurealso provides an open cell foam material that may be placed within asyringe assembly for mixing and stabilizing blood. For example, an opencell foam material may be used with an arterial blood gas syringe. Inthis manner, stabilized blood is dispensed for blood gas analysis.

FIGS. 9-13 illustrate an exemplary embodiment of a blood transfer deviceof the present disclosure. Referring to FIGS. 9-13, a blood transferdevice 300 adapted to receive a blood sample 302 includes a housing 304,an open cell foam material 306 having a dry anticoagulant powder 310therein, and a capillary tube 308.

Referring to FIGS. 9-13, housing 304 includes a first end 320, a secondend 322, a first portion 324, a second portion 326, a third portion 328,a finger grip 330 disposed between the second portion 326 and the thirdportion 328, an actuation member 332 transitionable between a firstposition and a second position, and a lid 334 movable between a closedposition in which the open cell foam material 306 is sealed within thehousing 304 and an open position in which a portion of the open cellfoam material 306 is exposed. With the lid 334 in the open position andthe open cell foam material 306 in contact with the blood sample 302,the blood sample 302 is absorbed within the open cell foam material 306and mixed with the dry anticoagulant powder 310 therein. In oneembodiment, the actuation member 332 is a push button formed of a rubbermaterial.

In one embodiment, open cell foam material 306 includes pores 312 and isdisposed within the housing 304 of the blood transfer device 300.Referring to FIGS. 9-13, in one embodiment, the open cell foam material306 is disposed within the first portion 324 of the housing 304. In oneembodiment, the open cell foam material 306 includes a dry anticoagulantpowder 310 within the pores 312 of the open cell foam material 306.

The open cell foam material 306 is adapted to receive a blood sample 302such that the blood sample 302 is mixed with the dry anticoagulantpowder 310 which is present inside the open cell foam material 306. Inthis manner, a stabilized blood sample may travel from the open cellfoam material 306 into capillary tube 308 for final metering anddispensing as described in more detail below.

In one embodiment, the open cell foam 306 is treated with ananticoagulant to form a dry anticoagulant powder 310 finely distributedthroughout the pores 312 of the open cell foam 306. The open cell foam306 may be loaded with a blood sample 302. The blood 302 gets soakedinto the open cell foam 306 based on capillary principles. As the blood302 is loaded into the open cell foam 306, the blood 302 is exposed tothe anticoagulant powder 310 throughout the internal micro porestructure of the open cell foam 306. The stabilized blood sample 302 maybe transferred to a diagnostic instrument such as a blood testingdevice, a point-of-care testing device, or similar analytical device.

As described above, a method of loading an anticoagulant to the opencell foam material 306 having pores 312 may include soaking the opencell foam material 306 in a liquid solution of the anticoagulant andwater; evaporating the water of the liquid solution; and forming a dryanticoagulant powder 310 within the pores 312 of the open cell foammaterial 306.

The, method of the present disclosure enables precisely controlledloading of an anticoagulant into the open cell foam material 306 bysoaking it with an anticoagulant and water solution and then drying theopen cell foam material 306 to form a finely distributed dryanticoagulant powder 310 throughout the pores 312 of the open cell foammaterial 306.

Anticoagulants such as Heparin or EDTA (Ethylene Diamine Tetra AceticAcid) as well as other blood stabilization agents could be introducedinto the open cell foam material 306 as a liquid solution by soaking theopen cell foam material 306 in the liquid solution of a desiredconcentration. After evaporating the liquid phase, e.g., evaporating thewater from a water and Heparin solution, a dry anticoagulant powder maybe formed and finely distributed throughout the internal structure ofthe open cell foam material 306. For example, the dry anticoagulantpowder may be finely distributed throughout the pores 312 of the opencell foam material 306. In a similar manner, the open cell foam material306 could be treated to provide a hydrophobic, hydrophilic, or reactiveinternal pore surface.

Referring to FIGS. 9-13, capillary tube 308 is in fluid communicationwith the open cell foam material 306 and a portion of the capillary tube308 is disposed within the housing 304 of the blood transfer device 300.The capillary tube 308 includes a first end 340, a dispensing tip 342,and an internal wall surface 344. The first end 340 of the capillarytube 308 is in fluid communication with the open cell foam material 306.In one embodiment, the internal wall surface 344 of the capillary tube308 includes an anticoagulant coating.

The capillary tube 308 is adapted to receive the blood sample 302 afterthe blood sample 302 is mixed with the dry anticoagulant powder 310within the open cell foam material 306. Referring to FIG. 13, with theblood sample 302 received within the capillary tube 308, movement of theactuation member 332 from the first position to the second positiondispenses the blood sample 302 through the dispensing tip 342 of thecapillary tube 308.

In one embodiment, the capillary tube 308 or the housing 304 of theblood transfer device 300 may include fill lines, such as graduationslocated on a sidewall 350 of blood transfer device 300, for providing anindication as to the level or amount of stabilized blood sample 302contained within capillary tube 308. Such markings may be provided on anexternal surface of sidewall 350, an internal surface of sidewall 350,or integrally formed or otherwise within sidewall 350 of blood transferdevice 300.

Referring to FIGS. 10-13, during the use of blood transfer device 300 tocollect a blood sample 302, stabilize the blood sample 302, e.g., mixthe blood sample 302 with an anticoagulant, meter the blood sample 302,and dispense the stabilized blood sample 302 to a diagnostic device, alancet device can be used to lance a skin surface S of a patient.

Next, referring to FIG. 10, the lid 334 is moved to the open position toexpose a portion of the open cell foam material 306. The blood transferdevice 300 is then positioned such that the open cell foam material 306is placed adjacent a punctured skin surface S of a patient so that theblood sample 302 can be transferred to the open cell foam material 306.For example, when a drop of blood 302 comes in contact with the opencell foam material 306, the blood 302 is instantly absorbed due to astrong capillary action of multiple open cell foam pores 312.

As the blood 302 is loaded into the open cell foam material 306, theblood 302 is exposed to the anticoagulant powder 310 throughout theinternal micro pore structure of the open cell foam material 306.Referring to FIGS. 11 and 12, once the open cell foam material 306 isloaded with the blood 302, the lid 334 is moved to the closed positionin which the open cell foam material 306 is sealed within the housing304 and the stabilized blood sample 302 is drawn from the open cell foammaterial 306 into the capillary tube 308.

Referring to FIG. 11, with the second end 322 of the blood transferdevice 300 positioned below the first end 320, the capillary bloodtransfer from the open cell foam material 306 to the capillary tube 308is improved. In one embodiment, the internal wall surface 344 of thecapillary tube 308 includes an anticoagulant coating to provide a secondstage of mixing for the stabilized blood sample 302.

The stabilized blood sample 302 is allowed to fill up the capillary tube308 to the appropriate marking or fill line, such as the graduationslocated on a sidewall 350 of blood transfer device 300 as describedabove. In one embodiment, the length of the capillary tube 308 up to amarking defines the volume of the blood sample collected, e.g., bloodmetering.

Referring to FIG. 13, movement of the actuation member 332 from thefirst position to the second position dispenses the stabilized bloodsample 302 through the dispensing tip 342 of the capillary tube 308. Forexample, the stabilized blood sample 302 may be dispensed from thecapillary tube 308 using air pressure. In one embodiment, the actuationmember 332 is a push button that can be pushed to dispense thestabilized blood sample 302. For example, when it is desired to expelthe stabilized blood sample 302 contained within capillary tube 308, theblood transfer device 300 may be grasped with the user's thumb onactuation member 332 of housing 304 and with the user's fingersextending around finger grip 330. Next, the user effects a squeezingmovement between the thumb on actuation member 332 of housing 304 andfour fingers grasping finger grip 330, thereby causing actuation member332 to be pushed or moved from the first position to the secondposition. In one embodiment, the stabilized blood sample 302 may betransferred to a diagnostic instrument such as a blood testing device.

The blood transfer device 300 includes an open cell foam material 306and a capillary tube 308 to collect a blood sample 302, stabilize theblood sample 302, e.g., mix the blood sample 302 with a dryanticoagulant powder 310 within the open cell foam material 306, meterthe blood sample 302, and dispense the stabilized blood sample to adiagnostic device.

Capillary blood samples may be transferred by capillary tubes that havean internal wall coated with a dry anticoagulant. Such capillary tubesmight result in insufficient blood mixing with the anticoagulant due tothe laminar nature of the capillary flow and slow diffusion kinetics ofthe dry anticoagulant. The blood transfer device 300 of the presentdisclosure enables more uniform mixing of a capillary blood sample bymixing the blood sample with a dry anticoagulant powder 310 within theopen cell foam material 306 before it enters the capillary tube 308 forfinal dispensing.

FIGS. 14-18 illustrate another exemplary embodiment of a blood transferdevice of the present disclosure. Referring to FIGS. 14-18, a bloodtransfer device 400 adapted to receive a blood sample 402 includes ahousing 404, an open cell foam material 406 having a dry anticoagulantpowder 410 therein, a first capillary tube 408, and a second capillarytube 414.

Referring to FIGS. 14-18, housing 404 includes a first end 420, a secondend 422, a first portion 424, a second portion 426, a third portion 428,a finger grip 430 disposed between the second portion 426 and the thirdportion 428, an actuation member 432 transitionable between a firstposition and a second position, and a lid 434 movable between a closedposition in which an inlet 460 of the first capillary tube 408 and theopen cell foam material 406 are sealed within the housing 404 and anopen position in which the inlet 460 of the first capillary tube 408 isexposed. With the lid 434 in the open position and the inlet 460 of thefirst capillary tube 408 in contact with the blood sample 402, the bloodsample 402 is transferred to the open cell foam material 406 via thefirst capillary tube 408 and mixed with the dry anticoagulant powder 410therein. In one embodiment, the actuation member 432 is a plunger.

In one embodiment, open cell foam material 406 includes pores 412 and isdisposed within the housing 404 of the blood transfer device 400.Referring to FIGS. 14-18, in one embodiment, the open cell foam material406 is disposed within the first portion 424 of the housing 404. In oneembodiment, the open cell foam material 406 includes a dry anticoagulantpowder 410 within the pores 412 of the open cell foam material 406.

As described above, the open cell foam material 406 is adapted toreceive a blood sample 402 such that the blood sample 402 is mixed withthe dry anticoagulant powder 410 which is present inside the open cellfoam material 406. In this manner, a stabilized blood sample may travelfrom the open cell foam material 406 into the second capillary tube 414for final metering and dispensing as described in more detail below.

In one embodiment, the open cell foam 406 is treated with ananticoagulant to form a dry anticoagulant powder 410 finely distributedthroughout the pores 412 of the open cell foam 406. The open cell foam406 may be loaded with a blood sample 402. The blood sample 402 istransferred to the open cell foam material 406 via the first capillarytube 408. As the blood 402 is loaded into the open cell foam 406, theblood 402 is exposed to the anticoagulant powder 410 throughout theinternal micro pore structure of the open cell foam 406. The stabilizedblood sample 402 may be transferred to a diagnostic instrument such as ablood testing device, a point-of-care testing device, or similaranalytical device.

In one embodiment, the open cell foam material 406 is a soft deformableopen cell foam that is inert to blood. In one embodiment, the open cellfoam material 406 is a Basotect® foam available from BASF. Such a foamis a Melamine foam which is an open cell foam material consisting of aformaldehyde-melamine-sodium bisulfite copolymer. The Melamine foam is aflexible, hydrophilic open cell foam that is resistant to heat and manyorganic solvents. In one embodiment, the open cell foam material 406 maybe a sponge material.

As described above, a method of loading an anticoagulant to the opencell foam material 406 having pores 412 may include soaking the opencell foam material 406 in a liquid solution of the anticoagulant andwater; evaporating the water of the liquid solution; and forming a dryanticoagulant powder 410 within the pores 412 of the open cell foammaterial 406.

The method of the present disclosure enables precisely controlledloading of an anticoagulant into the open cell foam material 406 bysoaking it with an anticoagulant and water solution and then drying theopen cell foam material 406 to form a finely distributed dryanticoagulant powder 410 throughout the pores 412 of the open cell foammaterial 406.

Anticoagulants such as Heparin or EDTA (Ethylene Diamine Tetra AceticAcid) as well as other blood stabilization agents could be introducedinto the open cell foam material 406 as a liquid solution by soaking theopen cell foam material 406 in the liquid solution of a desiredconcentration. After evaporating the liquid phase, e.g., evaporating thewater from a water and Heparin solution, a dry anticoagulant powder maybe formed and finely distributed throughout the internal structure ofthe open cell foam material 406. For example, the dry anticoagulantpowder may be finely distributed throughout the pores 412 of the opencell foam material 406. In a similar manner, the open cell foam material406 could be treated to provide a hydrophobic, hydrophilic, or reactiveinternal pore surface.

Referring to FIGS. 14-18, the blood transfer device 400 includes a firstcapillary tube 408 and a second capillary tube 414. The first capillarytube 408 is in fluid communication with the open cell foam material 406and is disposed between the first end 420 of the housing 404 and theopen cell foam material 406. The second capillary tube 414 is in fluidcommunication with the open cell foam material 406 and is disposedbetween the second end 422 of the housing 404 and the open cell foammaterial 406. Thus, the open cell foam material 406 is disposed betweenthe first capillary tube 408 and the second capillary tube 414. In thismanner, referring to FIG. 14, the housing 404, the first capillary tube408, and the second capillary tube 414 protects the open cell foammaterial 406 within the blood transfer device 400.

The first capillary tube 408 includes an inlet 460, a second end 462,and an internal wall surface 464. The first capillary tube 408 is influid communication with the open cell foam material 406 and a portionof the first capillary tube 408 is disposed within the housing 404 ofthe blood transfer device 400. The second end 462 of the first capillarytube 408 is in fluid communication with the open cell foam material 406.In one embodiment, the internal wall surface 464 of the first capillarytube 408 includes an anticoagulant coating.

Referring to FIG. 15, with the lid 434 of housing 404 in the openposition and the inlet 460 of the first capillary tube 408 in contactwith the blood sample 402, the blood sample 402 is transferred to theopen cell foam material 406 via the first capillary tube 408 and mixedwith the dry anticoagulant powder 410 therein.

The second capillary tube 414 includes a first end 470, a dispensing tip472, and an internal wall surface 474. The second capillary tube 414 isin fluid communication with the open cell foam material 406 and aportion of the second capillary tube 414 is disposed within the housing404 of the blood transfer device 400. The first end 470 of the secondcapillary tube 414 is in fluid communication with the open cell foammaterial 406. In one embodiment, the internal wall surface 474 of thesecond capillary tube 414 includes an anticoagulant coating.

The second capillary tube 414 is adapted to receive the blood sample 402after the blood sample 402 is mixed with the dry anticoagulant powder410 within the open cell foam material 406. Referring to FIG. 18, withthe blood sample 402 received within the second capillary tube 414,movement of the actuation member 432 from the first position to thesecond position dispenses the blood sample 402 through the dispensingtip 472 of the second capillary tube 414.

In one embodiment, the second capillary tube 414 or the housing 404 ofthe blood transfer device 400 may include fill lines, such asgraduations located on a sidewall 450 of blood transfer device 400, forproviding an indication as to the level or amount of stabilized bloodsample 402 contained within second capillary tube 414. Such markings maybe provided on an external surface of sidewall 450, an internal surfaceof sidewall 450, or integrally formed or otherwise within sidewall 450of blood transfer device 400.

Referring to FIGS. 14-18, in one embodiment, the first capillary tube408 and the second capillary tube 414 have different lengths. Forexample, in one embodiment, the first capillary tube 408 may be shorterthan the second capillary tube 414. In one embodiment, the firstcapillary tube 408 and the second capillary tube 414 have differentinternal diameters.

Referring to FIGS. 15-18, during the use of blood transfer device 400 tocollect a blood sample 402, stabilize the blood sample 402, e.g., mixthe blood sample 402 with an anticoagulant, meter the blood sample 402,and dispense the stabilized blood sample 402 to a diagnostic device, alancet device can be used to lance a skin surface S of a patient.

Next, referring to FIG. 15, the lid 434 is moved to the open position toexpose the inlet 460 of the first capillary tube 408. The blood transferdevice 400 is then positioned such that the inlet 460 of the firstcapillary tube 408 is placed adjacent a punctured skin surface S of apatient so that the blood sample 402 can be transferred to the open cellfoam material 406 via the first capillary tube 408.

As the blood 402 is loaded into the open cell foam material 406 via thefirst capillary tube 408, the blood 402 is exposed to the anticoagulantpowder 410 throughout the internal micro pore structure of the open cellfoam material 406. Referring to FIGS. 16 and 17, once the open cell foammaterial 406 is loaded with the blood 402, the lid 434 is moved to theclosed position in which the inlet 460 of the first capillary tube 408and the open cell foam material 406 are sealed within the housing 404and the stabilized blood sample 402 is drawn from the open cell foammaterial 406 into the second capillary tube 414.

Referring to FIG. 16, with the second end 422 of the blood transferdevice 400 positioned below the first end 420, the capillary bloodtransfer from the open cell foam material 406 to, the second capillarytube 414 is improved. In one embodiment, the internal wall surface 474of the second capillary tube 414 includes an anticoagulant coating toprovide a second stage of mixing for the stabilized blood sample 402.

The stabilized blood sample 402 is allowed to fill up the secondcapillary tube 414 to the appropriate marking or fill line, such as thegraduations located on a sidewall 450 of blood transfer device 400 asdescribed above. In one embodiment, the length of the second capillarytube 414 up to a marking defines the volume of the blood samplecollected, e.g., blood metering.

Referring to FIG. 18, movement of the actuation member 432 from thefirst position to the second position dispenses the stabilized bloodsample 402 through the dispensing tip 472 of the second capillary tube414. For example, the stabilized blood sample 402 may be dispensed fromthe second capillary tube 414 using air pressure. In one embodiment, theactuation member 432 is a plunger that can be pushed to dispense thestabilized blood sample 402. For example, when it is desired to expelthe stabilized blood sample 402 contained within second capillary tube414, the blood transfer device 400 may be grasped with the user's thumbon actuation member 432 of housing 404 and with the user's fingersextending around finger grip 430. Next, the user effects a squeezingmovement between the thumb on actuation member 432 of housing 404 andfour fingers grasping finger grip 430, thereby causing actuation member432 to be pushed or moved from the first position to the secondposition. In one embodiment, the stabilized blood sample 402 may betransferred to a diagnostic instrument such as a blood testing device.

The blood transfer device 400 includes an open cell foam material 406and a first capillary tube 408 and second capillary tube 414 to collecta blood sample 402, stabilize the blood sample 402, e.g., mix the bloodsample 402 with a dry anticoagulant powder 410 within the open cell foammaterial 406, meter the blood sample 402, and dispense the stabilizedblood sample to a diagnostic device.

Capillary blood samples may be transferred by capillary tubes that havean internal wall coated with a dry anticoagulant. Such capillary tubesmight result in insufficient blood mixing with the anticoagulant due tothe laminar nature of the capillary flow and slow diffusion kinetics ofthe dry anticoagulant. The blood transfer device 400 of the presentdisclosure enables more uniform mixing of a capillary blood sample bymixing the blood sample with a dry anticoagulant powder 410 within theopen cell foam material 406 before it enters the second capillary tube414 for final dispensing.

FIGS. 19 and 20 illustrate an exemplary embodiment of a syringe assemblyof the present disclosure. Referring to FIGS. 19 and 20, a syringeassembly 500 includes an open cell foam material 502 having a dryanticoagulant powder 504 therein. The open cell foam material 502 isdisposed within the syringe assembly 500.

In one embodiment, the syringe assembly 500 includes a syringe barrel506 having a first end 508, a second end 510, and a sidewall 512extending therebetween and defining an interior 514. Referring to FIGS.19 and 20, the open cell foam material 502 is disposed within theinterior 514 of the syringe barrel 506.

In one embodiment, the syringe assembly 500 includes a plunger rod 516and a stopper 518. The plunger rod 516 includes a first end and a secondend. The stopper 518 is engaged with the second end 522 of the plungerrod 516 and is slidably disposed within the interior 514 of the syringebarrel 506. The stopper 518 is sized relative to the interior 514 of thesyringe barrel 506 to provide sealing engagement with the sidewall 512of the syringe barrel 506.

The open cell foam material 502 is placed in the syringe barrel 506 formixing and stabilizing blood. The blood gets collected in the syringebarrel 506 with the open cell foam material 502 embedded inside thesyringe barrel 506. The stabilized blood can then be dispensed foranalysis. In one embodiment, the syringe assembly is an arterial bloodgas syringe and the stabilized blood can be dispensed for blood gasanalysis.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. A specimen transfer and testing system,comprising: a specimen transfer device adapted to receive a sample,comprising: a housing having a first end, a second end, a sidewallextending therebetween, a dispensing tip at the first end, an actuationmember at the second end, and a valve disposed within the dispensingtip, the actuation member movable between a first position and a secondposition, the valve transitionable between a closed position and an openposition; a deformable material having pores and disposed within thehousing, the material deformable from an initial position in which thematerial is adapted to contain the sample to a deformed position inwhich at least a portion of the sample is released from the material;and a viscoelastic member disposed within the housing between thematerial and the sidewall of the housing and between the material andthe actuation member, wherein the viscoelastic member is engaged withthe actuation member and the material such that movement of theactuation member from the first position to the second position exerts aforce on the viscoelastic member which deforms the material from theinitial position to the deformed position, and wherein with the materialin the deformed position and the valve in the open position, the portionof the sample released from the material may flow through the dispensingtip; and a sample testing device having a receiving port adapted toreceive the dispensing tip of the specimen transfer device for closedtransfer of at least a portion of the sample from the specimen transferdevice to the sample testing device.
 2. The specimen transfer andtesting system of claim 1, wherein the specimen transfer device furthercomprises a dry anticoagulant powder within the pores of the material.3. The specimen transfer and testing system of claim 1, wherein theviscoelastic member has a viscoelastic member hardness, the actuationmember has an actuation member hardness, and wherein the viscoelasticmember hardness is less than the actuation member hardness.
 4. Thespecimen transfer and testing system of claim 1, wherein the actuationmember is a push button.
 5. The specimen transfer and testing system ofclaim 1, wherein the specimen is blood.